Search results for "regulated software"
showing 2 items of 2 documents
Introducing Traceability in GitHub for Medical Software Development
2021
Assuring traceability from requirements to implementation is a key element when developing safety critical software systems. Traditionally, this traceability is ensured by a waterfall-like process, where phases follow each other, and tracing between different phases can be managed. However, new software development paradigms, such as continuous software engineering and DevOps, which encourage a steady stream of new features, committed by developers in a seemingly uncontrolled fashion in terms of former phasing, challenge this view. In this paper, we introduce our approach that adds traceability capabilities to GitHub, so that the developers can act like they normally do in GitHub context bu…
Continuous design control for machine learning in certified medical systems
2022
AbstractContinuous software engineering has become commonplace in numerous fields. However, in regulating intensive sectors, where additional concerns need to be taken into account, it is often considered difficult to apply continuous development approaches, such as devops. In this paper, we present an approach for using pull requests as design controls, and apply this approach to machine learning in certified medical systems leveraging model cards, a novel technique developed to add explainability to machine learning systems, as a regulatory audit trail. The approach is demonstrated with an industrial system that we have used previously to show how medical systems can be developed in a con…